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How to Validate Equipment According to FDA Standards Webinar  

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Online Compliance Panel   

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This webinar is intended for formulators, process engineers, validation, regulatory compliance and quality assurance personnel, as well as production managers who want to ensure that their equipment and processes are in compliance with validation requirements of various regulatory bodies and directives.

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Seminar Summary:

Get trained on practical aspects of FDA process validation, equipment qualification, Data analysis, statistical tools for Process Quality Management, more. (see full course description)

 

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Training Course Syllabus:


How to Validate Equipment According to FDA Standards Webinar

This webinar course covers the following topics on validation of pharmaceutical product and process:

  • FDA Guidance on Process Validation: general principles and practices

  • Lifecycle and Process Validation

  • ICH Q10, FDA and EU - focus on validation

  • cGMP regulations and Process Validation Guidance

  • Data analysis and statistical tools for Process Quality Management (PQM)

  • Examples of statistical tools and ASTM standards

  • Process Verification vs. Process Validation

Why Should you Attend:

This webinar will provide an excellent insight into the practical aspects of the Process Validation and equipment qualification which will be an invaluable source of information related to regulatory activity.

Objectives of the Presentation:

This presentation aims at teaching participants about:


  • Qualification vs. validation vs. verification

  • Regulations for Process Validation: Review of FDA, GHTF, and GAMP requirements

  • Documentation and testing: Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ)

  • Acceptance criteria of equipment qualification Process Validation

  • Validation Protocol as per FDA standards

Seminar Summary:

Get trained on practical aspects of FDA process validation, equipment qualification, Data analysis, statistical tools for Process Quality Management, more. (see full course description)

print this agenda print agenda for the How to Validate Equipment According to FDA Standards Webinar training seminar

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